1.

Declare that Iceland has failed to fulfil its obligations under Article 7 of the EEA Agreement by failing to make the Act referred to at point 6 of Annex XVII to the EEA Agreement (Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products), as adapted by Protocol 1 to the EEA Agreement, part of its internal legal order, as such, and

2.

Order Iceland to bear the costs of these proceedings.

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By this application, the EFTA Surveillance Authority (‘ESA’) seeks a declaration from the Court that Iceland has failed to adopt the measures necessary to make the Act referred to at point 6 of Annex XVII to the EEA Agreement, as adapted by Protocol 1 to that Agreement, part of its internal legal order, as such, as required by Article 7 EEA.

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Iceland did not reply to ESA’s letter of formal notice of 22 September 2023.

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ESA delivered a reasoned opinion on 6 March 2024 giving Iceland two months in which to take the measures necessary to comply with the reasoned opinion, i.e. no later than 6 May 2024.

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No response from Iceland was received by ESA within the time-frame specified in the reasoned opinion.

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Since Iceland had not complied with the reasoned opinion by the deadline set therein, ESA decided to refer the matter to the Court, pursuant to Article 31 SCA.

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ESA notes that, at the point of lodging the present application, Iceland had not informed ESA of any measures adopted to make the Act part of its internal legal order. Moreover, ESA was not in possession of any other information which indicated that the act had been made part of Iceland’s internal legal order.